US20130071048A1 - Container filled with a liquid concentrate for making dialysate - Google Patents
Container filled with a liquid concentrate for making dialysate Download PDFInfo
- Publication number
- US20130071048A1 US20130071048A1 US13/570,124 US201213570124A US2013071048A1 US 20130071048 A1 US20130071048 A1 US 20130071048A1 US 201213570124 A US201213570124 A US 201213570124A US 2013071048 A1 US2013071048 A1 US 2013071048A1
- Authority
- US
- United States
- Prior art keywords
- side wall
- bag
- edges
- self
- points
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 235000014666 liquid concentrate Nutrition 0.000 title description 8
- 238000007789 sealing Methods 0.000 claims abstract description 71
- 239000000463 material Substances 0.000 claims description 25
- 238000005304 joining Methods 0.000 claims description 23
- 239000007788 liquid Substances 0.000 claims description 19
- 239000012141 concentrate Substances 0.000 claims description 18
- 238000011282 treatment Methods 0.000 claims description 15
- 239000004698 Polyethylene Substances 0.000 claims description 10
- 238000000502 dialysis Methods 0.000 claims description 10
- 239000004743 Polypropylene Substances 0.000 claims description 7
- 238000005520 cutting process Methods 0.000 claims description 6
- 229920000573 polyethylene Polymers 0.000 claims description 6
- -1 polyethylene Polymers 0.000 claims description 4
- 229920001155 polypropylene Polymers 0.000 claims description 4
- 239000004952 Polyamide Substances 0.000 claims description 2
- 229920002647 polyamide Polymers 0.000 claims description 2
- 238000003466 welding Methods 0.000 description 26
- 235000008504 concentrate Nutrition 0.000 description 17
- 238000000034 method Methods 0.000 description 13
- 239000008280 blood Substances 0.000 description 10
- 210000004369 blood Anatomy 0.000 description 10
- 238000001631 haemodialysis Methods 0.000 description 8
- 230000000322 hemodialysis Effects 0.000 description 8
- 238000004519 manufacturing process Methods 0.000 description 6
- 239000000126 substance Substances 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 239000012530 fluid Substances 0.000 description 5
- 230000008569 process Effects 0.000 description 5
- 210000003734 kidney Anatomy 0.000 description 3
- 238000002844 melting Methods 0.000 description 3
- 230000008018 melting Effects 0.000 description 3
- 210000004379 membrane Anatomy 0.000 description 3
- 239000012528 membrane Substances 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 239000000385 dialysis solution Substances 0.000 description 2
- 238000009792 diffusion process Methods 0.000 description 2
- 230000003292 diminished effect Effects 0.000 description 2
- 239000013536 elastomeric material Substances 0.000 description 2
- 239000003792 electrolyte Substances 0.000 description 2
- 238000006467 substitution reaction Methods 0.000 description 2
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 description 1
- 208000001647 Renal Insufficiency Diseases 0.000 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
- 238000004026 adhesive bonding Methods 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 238000002615 hemofiltration Methods 0.000 description 1
- 201000006370 kidney failure Diseases 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 210000003200 peritoneal cavity Anatomy 0.000 description 1
- 210000004303 peritoneum Anatomy 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000004080 punching Methods 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 239000002002 slurry Substances 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
- A61M1/1668—Details of containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
- A61M1/1668—Details of containers
- A61M1/167—Flexible packaging for solid concentrates
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
- B29C65/08—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using ultrasonic vibrations
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
- B29C65/18—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D31/00—Bags or like containers made of paper and having structural provision for thickness of contents
- B65D31/005—Bags or like containers made of paper and having structural provision for thickness of contents by folding a single blank to U-shape to form the base of the bag and opposite sides of the body-portion, the remaining sides being formed by extensions of one or more of these opposite sides
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D33/00—Details of, or accessories for, sacks or bags
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
- B65D75/008—Standing pouches, i.e. "Standbeutel"
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B2150/00—Flexible containers made from sheets or blanks, e.g. from flattened tubes
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B2150/00—Flexible containers made from sheets or blanks, e.g. from flattened tubes
- B31B2150/002—Flexible containers made from sheets or blanks, e.g. from flattened tubes by joining superimposed sheets, e.g. with separate bottom sheets
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B2155/00—Flexible containers made from webs
- B31B2155/002—Flexible containers made from webs by joining superimposed webs, e.g. with separate bottom webs
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B2160/00—Shape of flexible containers
- B31B2160/20—Shape of flexible containers with structural provision for thickness of contents
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B70/00—Making flexible containers, e.g. envelopes or bags
- B31B70/008—Stiffening or reinforcing
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S383/00—Flexible bags
- Y10S383/903—Stress relief
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S383/00—Flexible bags
- Y10S383/907—Peculiar, particular shape
Definitions
- the invention relates to the field of containers for providing liquid concentrates for making ready-to-use dialysis fluid for a dialysis treatment of a patient by an artificial kidney.
- peritoneal dialysis dialysis fluid is conducted via special implanted catheters to the peritoneal cavity of a patient and regularly exchanged with fresh fluid, thus purifying the human blood by diffusion of substances to be removed and by extracting excess water by osmotic pressure gradients through the peritoneum of the patient.
- the blood of a patient is circulated in an extracorporeal blood circuit for several hours.
- the blood passes the blood chamber of a dialyser where a semipermeable membrane, most commonly in the shape of thousands of hollow fibres, separates a blood chamber from a dialysate chamber that is part of a dialysate circuit.
- the blood is purified from substances to be removed by diffusion through the membrane as such substances are 20 usually not contained in the dialysate flowing into the dialysate chamber.
- Other substances that are to be retained in the blood at least in certain concentrations and that can also pass the membranes like electrolytes are contained in the fresh dialysate in physiological concentrations.
- the dialysate required for the hemodialysis treatment during the treatment from concentrates and water in a single-pass system, i.e. the prepared dialysate only passes the dialyser once and is discarded thereafter.
- the first or “A”-component usually consists of an acidic part that also contains most of the required electrolytes.
- the second or “B”-component consists mainly of sodium bicarbonate in this case.
- the second component can also be delivered in dry powder form, the first component is still widely distributed as a fluid in rigid containers if no central concentrate supply system exists where the concentrate is prepared at a central location and then distributed to the treatment places via a piping network.
- Typical dilution ratios of the A-component with water are about 1+33, 1+34 or 1+44, the B-component contributing further shares between 1 to 2 parts of liquid.
- Common dialysate flow rates for a hemodialysis treatment are of the order of 500 mllmin. Taking a four hour treatment a liquid volume of about 120 litres has to be circulated through the dialysate chamber requiring concentrate volumes of at least 3 to 4 litres each.
- liquid dialysate concentrates contain 5 or more litres of liquid concentrate.
- dialysate prepared by diluting the concentrates with water on-line during a treatment of a patient may also be used as substitution liquid in the case of a hemofiltration or hemodiafiltration treatment.
- Today many treatment devices also provide for such on-line substitution modes leading to an even higher demand of liquid concentrates.
- a container filled with a liquid dialysate for making dialysate for a dialysis treatment characterised in that the container is a self-standing bag made of flexible elastomeric sheets.
- the invention is based on the observation that in other technical fields self-standing bags made of flexible elastomeric sheets are in wide-spread use. Such bags require much less material for their production and much less space when being empty. However, there appeared to be the prejudice in the field of dialysis that such bags are not suitable for the manufacture of containers for liquid concentrates for dialysis. In fact the weight of several kilograrnms of liquid is large for a flexible bag bearing the risk that a bag may crack during use or not rest in a stable position to allow the extraction of the concentrate through the suction pipe of the hemodialysis device during a treatment procedure.
- a self-standing bag is understood to be a bag having its barycentre well defined above its bottom standing area when being filled with a medium so that the filled bag rests in a stable standing orientation on its own.
- this bag is made from two elastomeric flexible side wall sheets having rectangular shape with horizontal top and bottom and two vertical edges, and one elastomeric flexible bottom wall sheet also having rectangular shape with two horizontal and two vertical edges.
- this bag may be put into a flat configuration where the bottom wall sheet is sandwiched between the two elastomeric side wall sheets and wherein the bottom wall sheet is symmetrically single-folded parallel to its horizontal edges and the horizontal edges of the bottom wall sheet coincide with the horizontal bottom edges of the two side wall sheets.
- the empty bag is thus divided into a lateral four-layer part in the lower part of the bag and a lateral two-layer part in the upper part of the bag.
- a connector part can conveniently be sandwiched between the two horizontal top edges of the side wall sheets wherein the two horizontal top edges and the connector part are joined in a fluid tight way by a seal, preferably a welding line.
- several parts of the bag are jointly sealed, preferably by welding: the vertical edges of the side wall sheets in the lateral two-layer part, the vertical edges of the bottom wall sheet with the neighbouring parts of the side wall sheets, and the horizontal edges of the bottom wall sheet with the neighbouring horizontal bottom edges of the side wall sheets.
- a preferred embodiment of the bag comprises first sloped sealing lines on each side of the bag joining the side wall sheets in the lateral two-layer part between first points on the horizontal top edges of the side wall sheets that are recessed from the outer ends of the horizontal edges, in other words, the first points on the horizontal top edges of the side wall sheets are spaced from the vertical edges of the side wall sheets, and second points that are along or spaced from the vertical edges of the side wall sheets and that are positioned on the line separating the lateral two-layer part from the lateral four-layer part.
- Second sloped sealing lines join each side wall sheet and the neighbouring bottom wall sheet in the lateral four-layer part on each side of the bag between third points on the horizontal bottom edges that are recessed from the outer ends of the horizontal edges, in other words, the third points are spaced from the vertical edges of the side wall sheets, and the second points.
- the second points may be recessed from the vertical edges of the side wall sheets and the bag may comprise further horizontal sealing lines between the second points and the neighbouring vertical edges of the side wall sheets along the line separating the two-layer part from the four-layer part thus joining all four layers along these horizontal sealing lines.
- the self-standing bag there are third sloped sealing lines on each side of the bag between the third points and fourth points on the vertical edges of both the side wall sheets and the bottom wall sheet in the four-layer part joining only the bottom wall sheet and the neighbouring side wall sheet. Additional fourth sloped sealing lines on each side of the bag between the second and the fourth points joining only the bottom wall sheet and the neighbouring side wall sheet further contribute to the stability of the self-standing bag.
- the first, second and fourth sloped sealing lines, but not the third sloped sealing lines exist. Instead the sheet material of the side wall sheets and the bottom wall sheet in the corner areas below the second sloped sealing lines and below cutting edges leading from the fourth points to fifth points on the second sloped sealing lines is removed.
- the cutting edges may be reinforced by fifth sloped sealing lines on each side of the bag between the fourth and the fifth points joining only the bottom wall sheet ( 4 ) and the neighbouring side wall sheet. In this case a beak-like flap is formed on both sides of the bag that protects the zone around the second points where four sheets of the side wall sheets and the bottom wall sheet are joined.
- sealing lines are preferably created by welding techniques, but generally other joining processes like gluing are also possible. In special cases a sealing line may simply be established by folding a larger sheet along the required line. Such embodiments are hereby explicitly encompassed by using the expression “seal” throughout this document. Furthermore, the sealing lines are preferably straight lines.
- the sheet material of the bottom wall sheet between the fourth sloped sealing lines and the vertical edges has been removing, preferably by punching. Both side wall sheets can therefore directly be joined in this area thus avoiding welding areas consisting of four layers of elastomeric sheets that could give rise to problems in reliable sealing the outer layers.
- the second sloped sealing line may at least partly be a peel seam that is adapted to absorb excessive pressure in the bag. Should high pressure suddenly develop in the bag as in the case of a crash of the bag on a hard floor the peel seam can at least partly open whereby the pressure is diminished in a controlled manner minimising the risk that the bag gets cracks.
- dialysate liquid concentrates in a bag made of elastomeric flexible sheets with common volumes of 3 to 8 litres, preferably 5 to 6 litres.
- a bag could also be delivered containing just a dry or slurry concentrate that when being diluted with water directly before use produces the same amount of dialysate liquid concentrate that is sufficient for a whole blood treatment of a patient.
- a further advantageous embodiment makes use of a layered bottom wall sheet wherein the two outer layers consist of different materials.
- Using the same material for one outer layer of the bottom wall sheet and the side wall sheets or at least the outer layer of the side wall sheets facing each other further simplifies the manufacture of certain embodiments of the self-standing bag according to the invention as the stability of a bag area where four sheets would have to be joined by welding can be enhanced without the removal of parts of the bottom wall sheet.
- FIG. 1 a shows a first embodiment of the self-standing bag according to the invention in an empty, flat configuration
- FIG. 1 b a lateral cross-section of the bag as indicated in FIG. 1 a
- FIG. 2 the bag of FIG. 1 a in a three-dimensional configuration when being filled
- FIG. 3 the joining of the bottom and side wall sheets of the bag of FIG. 2 ,
- FIG. 4 the bag of FIG. 2 with peel seams to absorb pressure waves
- FIG. 5 an alternative embodiment of the bag of FIG. 2 for avoiding any damage in the case of excessive pressure
- FIG. 6 a table for preferred geometries of the example embodiments of the bag according to the invention.
- FIG. 7 a second embodiment of the self-standing bag according to the invention in an empty, flat configuration
- FIG. 8 the bag of FIG. 7 in a three-dimensional configuration when being filled
- FIG. 9 the joining of the bottom and side wall sheets of the bag of FIG. 8 .
- FIG. 10 a third embodiment of the self-standing bag according to the invention showing a view similar to FIG. 9 for the second embodiment.
- FIG. 1 a a first embodiment of the self-standing bag 1 according to the invention is shown in a flat configuration directly after having been manufactured and before the bag 1 is filled with liquid dialysate concentrate.
- FIG. 1 b presents a lateral cross-section of the bag 1 as indicated in FIG. 1 a .
- the self-standing bag 1 is made from three rectangular sheets of flexible elastomeric material: two similar side wall sheets 2 and and one bottom wall sheet 4 .
- the bottom wall sheet 4 is sandwiched between the side wall sheets 2 and 3 wherein the bottom wall sheet 4 is symmetrically single-folded parallel to its horizontal edges 4 a and 4 b , and the horizontal edges of the bottom wall sheet coincide with the horizontal bottom edges 2 a and 3 a of the two side wall sheets 2 and 3 .
- the empty bag is thus divided into a lateral four-layer part 30 and a lateral two-layer part 20 .
- the vertical edges 2 c and 2 d of the first side wall sheet and 3 c and 3 d of the second side wall sheet coincide with each other and with the folded vertical edges 4 c and 4 d of the bottom wall sheet.
- the two horizontal top edges 2 b and 3 b are joined by a seal 10 wherein a connector part may be sandwiched and sealed between the side wall sheets in a part of the sealing line 10 (not shown in FIGS. 1 a and 1 b ).
- the vertical edges 2 c , 2 d and 3 c , 3 d of the side wall sheets are joined by seals 11 ′ and 11 ′′ in the lateral two-layer part 20 (an apostrophe in a reference sign shall denote parts on the left hand side of the bag and a double apostrophe the corresponding symmetric part on the right hand side in this patent document).
- the vertical edges 4 c and 4 d of the bottom wall sheet are joined with the neighbouring parts of the side wall sheets 2 and 3 by further seals 12 a ′, 12 b ′ and 12 a ′′, 12 b ′′ (for parts that exist in the lateral four-layer part twice the suffix “a” is used in this patent document to denote an item that originates from the first side wall sheet 2 and the bottom wall sheet 4 whereas the suffix “b” is used to denote the corresponding symmetric item that originates from the second side wall sheet 3 and the bottom wall sheet 4 ).
- the horizontal edges 4 a and 4 b of the bottom wall sheet are joined with the neighbouring horizontal bottom edges 2 a and 3 a of the side wall sheets by seals 18 a , 18 b , thereby providing a sealed volume in the middle of the bag.
- the side wall sheets 2 and 3 and the bottom wall sheet 4 may be made from a single web wherein the horizontal bottom edges 2 a , 3 a of the side wall sheets and 4 a , 4 b of the bottom wall sheet are made by folding the web along the horizontal edges.
- folding lines are considered to be sealing lines in the context of the present invention.
- manufacture the bag from a flat tubular film where the folded edges of the tubular film either represent the vertical or the horizontal edges of the side wall sheets.
- other sealing lines can be realised by folding lines without departing from the concept of the present invention.
- the embodiment shown in FIG. 1 a further comprises first sloped sealing lines 13 ′, 13 ′′ between the side wall sheets 2 and 3 in the lateral two-layer part 20 on each side of the bag between first points A′, A′′ on the horizontal top edges sealing line 10 , that are recessed by a first distance a from the ends of the horizontal edges, and second points B′, B′′ that are less or not recessed by a second distance b from the vertical edges 2 c , 3 c and 2 d , 3 d , respectively, of the side wall sheets.
- the second points B′, B′′ are positioned on the line separating the lateral two-layer part 20 from the lateral four-layer part 30 .
- the self-standing bag 1 also comprises second sloped sealing lines 14 a ′, 14 b ′ and 14 a ′′ and 14 b ′′ joining each side wall sheet 2 , 3 and the neighbouring bottom wall sheet 4 in the lateral four-layer part 30 on each side of the bag between third points C 1 ′, C 2 ′ and C 1 ′′, C 2 ′′ on the horizontal bottom edges 2 a , 3 a , that are recessed by a third distance c from the ends of the horizontal bottom edges, and the second points B′, B′′.
- the second distance b is small compared with the first and third distances a and c. In the embodiment shown in FIG. 1 a the first and third distances a and c are identical.
- the bag 1 further comprises horizontal sealing lines 15 ′, 15 ′′ between the second points B′, B′′ and the neighbouring vertical edges 2 c , 3 c and 2 d , 3 d of the side wall sheets wherein the horizontal sealing lines 15 ′, 15 ′′ join all four sheets in this region.
- the bag 1 also contains third sloped sealing lines 16 a ′, 16 b ′ and 16 a′′, 16 b′′ on each side of the bag between the third points C 1 ′, C 2 ′ and C 1 ′′, C 2 ′′ and fourth points D 1 ′, D 2 ′ and D 1 ′′, D 2 ′′ on the vertical edges 2 c , 3 c and 2 d , 3 d of both side wall sheets and the vertical edges 4 c , 4 d of the bottom wall sheet in the four-layer part 30 joining only the bottom wall sheet 4 and the neighbouring side wall sheet 2 or 3 .
- the fourth points D 1 ′, D 2 ′ and D 1 ′′, D 2 ′′ are recessed from the bottom horizontal edges 2 a , 3 a by fourth distances d.
- the self-standing bag 1 comprises fourth sloped sealing lines 17 a ′, 17 b ′ and 17 a ′′, 17 b ′′ on each side of the bag between the second points B′, B′′ and the fourth points D 1 ′, D 2 ′ and D 1 ′′, D 2 ′′ joining only the bottom wall sheet 4 and the neighbouring side wall sheet 2 or 3 .
- All sealing lines are preferably produced by welding techniques for which a manifold of processes are available for those skilled in the art.
- the welding may be carried out by applying heat directly, using ultrasonic waves or laser irradiation.
- the bag After the bag has been filled with liquid dialysate concentrate it assumes a three-dimensional shape as can be seen in FIG. 2 .
- the liquid itself is not depicted in FIG. 2 .
- the self-standing bag has a squared bottom plane 40 whereas the interior has a wedge shaped volume with decreasing horizontal cross-section when going from the bottom to the top of the bag 1 .
- This provides for a centre-of-gravity at low height and thus for an improved stability of the bag.
- the stability is also enhanced horizontally by the bottom side flaps 41 a ′, 41 b ′ and 41 a ′′, 41 b ′′ and vertically by the top side flaps 42 ′ and 42 ′′.
- a connector part 50 Also shown in FIG. 2 is a connector part 50 that is sealed in a sandwiching manner between the side wall sheets 2 and 3 in the sealing line zone 10 .
- FIG. 3 shows the joining process of the two side wall sheets 2 and 3 and the bottom wall sheet 4 in detail.
- this would require to also join the corresponding parts of the bottom wall sheet 4 i.e. altogether four layers of elastomeric material would have to be welded together.
- Such welding procedures always bear the danger that a seal between any of the layers may be incomplete thus giving rise to increased instability and to forces that may damage other sealing lines and thus the integrity of the whole bag.
- some of the sealing lines may at least partly consist of peel seams.
- FIG. 4 the bag of FIG. 2 is shown wherein the first sloped sealing lines 13 ′, 13 ′′ are made of such peelable seams. Should a pressure wave as a result of excessive pressure in the bag hit the various sealing lines of the bag the peel seams 13 ′, 13 ′′ can partly or completely open, thereby absorbing and reducing the pressure and relieving the other sealing lines from a critical pressure condition.
- FIG. 5 An alternative solution to absorb excessive pressure is provided in FIG. 5 .
- the first sloped sealing lines 13 ′, 13 ′′ are interrupted at the top of the bag. Should the bag be dropped (step 1 ) the pressure wave (step 2 ) expands into all directions and also to the air remaining at the top of the container (step 3 ), which further expands into the top side flap chambers 42 ′, 42 ′′ (step 4 ).
- the total sealing line length is larger in this case as for the bag shown in FIG. 2 and as the air or liquid can also expand within the flexible flaps 42 ′, 42 ′′ the pressure in the whole bag can significantly be reduced.
- the first sloped sealing lines 13 ′, 13 ′′ are only interrupted at a small length compared to their total length the stability of the bag 1 is not diminished.
- the bag according to the invention it is possible to provide 3 to 8 litres, preferably 5 to 6 litres of liquid dialysate concentrate in a self-standing bag made of elastomeric and flexible material sheets.
- the design of the bag guarantees that the bag remains in a stable upright position during use even when the bag contains less and lesser liquid at the end of a hemodialysis treatment.
- FIGS. 1 to 5 Preferred geometries of the embodiment of a self-standing bag according to the invention as shown in the FIGS. 1 to 5 are provided in FIG. 6 .
- the self-standing bag 1 most conveniently contains a rigid connector part 50 as shown in FIGS. 2 , 4 and 5 .
- the connector part 50 has a wide middle part section and two tapered side wing parts to enable smooth transitions for the top sealing line 10 .
- An orifice 53 in the wide middle part has a diameter large enough for a suction pipe of a dialysis device to reach into the interior of the bag. Any air tight sealing between the bag and the suction pipe is not necessary as in the case of conventional containers made of rigid material.
- the orifice 53 may comprise an inner, smaller orifice (not shown) as spill barrier.
- the orifice can be closed after the bag has been filled by a tamper-proved lid 51 that may also be used to re-close the bag after use.
- the connector part 50 preferably comprises a handle 52 by which the whole bag can easily be carried.
- the handle 52 is linked to the main part of the connector 50 by suitable joints so that the handle 52 can be moved out of the way of the orifice 53 of the connector part 50 when a suction pipe is to be inserted into the bag.
- a peelable disposable sheet may also be used to close the bag after filling, e.g. by appropriate heat sealing to the orifice 53 .
- Such an embodiment is less costly and also provides a single-use indication as the sheet cannot be applied to the orifice again once it has been removed.
- FIG. 7 a second embodiment of the self-standing bag 1 according to the invention is shown in a view similar to that of FIG. 1 a .
- the same reference numbers are used for identical parts of both embodiments of the bag.
- the cross-section as displayed in FIG. 1 b is the same for the second embodiment which is why this view is omitted here.
- the bag 1 shown in FIG. 7 also comprises the first sloped sealing lines 13 ′, 13 ′′ between the first points A′, A′′ and the second points B′, B′′, the second sloped lines 14 a ′, 14 a ′′ and 14 b ′, 14 b ′′ between the second points B′, B′′ and the third points C 1 ′, C 1 ′′ and C 2 ′, C 2 ′′ and the fourth sloped sealing lines 17 a ′, 17 a ′′ and 17 b ′, 17 b ′′ between the second points B′, B′′ and the fourth points D 1 ′, D 1 ′′ and D 2 ′, D 2 ′′.
- the third sealing lines of the first embodiment are not present in the second embodiment.
- the bag 1 may comprise fifth sloped sealing lines 19 a ′, 19 a ′′ and 19 b ′, 19 b ′′, preferably welding lines, on each side of the bag between the fourth and the fifth points joining only the bottom wall sheet 4 and the neighbouring side wall sheet 2 ; 3 directly at the cutting edges 48 a ′, 48 a ′′ and 48 b ′, 48 b ′′.
- FIG. 8 shows the self-standing bag 1 according to the second embodiment of the invention in a three-dimensional configuration when being filled similar to the view of FIG. 2 .
- the liquid itself is again not depicted.
- the inner part of the self-standing bag 1 is similar for both embodiments which leads to a comparable position of the centre-of-gravity.
- the vertical stability is also enhanced by the top side flaps 42 ′ and 42 ′′ and the sealing lines at their edges.
- the horizontal stability is achieved by the second sloped sealing lines 14 a ′, 14 b ′ and 14 a ′′, 14 b ′′ and the creation of beak-like flaps 46 a ′, 46 b ′ and 46 a ′′, 46 b ′′ on both sides of the filled bag 1 .
- These beak-like flaps protect the zones around the second points B′, B′′, where four sheets of the side wall sheets and the bottom wall sheet are joined, from any stress that results from the fluid inside the bag 1 statically and dynamically when the bag is moved or dropped.
- the flaps enhance the horizontal stability of the second sloped sealing lines as they provide a constraint between the second sloped sealing lines 14 a ′, 14 a ′′ between the one side wall sheet 2 and the bottom wall sheet 4 and the corresponding second sloped sealing lines 14 b ′, 14 b ′′ between the other side wall sheet 3 and the bottom wall sheet 4 .
- FIG. 9 the joining of the bottom and side wall sheets of the bag can be realised for the second embodiment of the self-standing bag 1 similarly as in the case of the first embodiment.
- the description of FIG. 3 therefore applies mutatis mutandis to FIG. 9 .
- the concepts as disclosed in FIGS. 4 and 5 can easily be combined with the design of the self-standing bag according to the second embodiment.
- Preferred geometries of the second embodiment of the self-standing bag according to the invention are also compiled in the table of FIG. 6 .
- FIG. 10 shows an alternative for the joining of the bottom and side wall sheets according to a third embodiment of the self-standing bag according to the invention.
- the third embodiment is similar to the second embodiment but the parts 45 a ′ and 45 b ′ of the bottom wall sheet 4 are not punched out and removed before all sheets are joined. Instead a welding between the areas 43 ′ and 44 ′ of the two side wall sheets 2 and 3 together with the sandwiched folded layers from the bottom wall sheet 4 can be established. Without the modification according to the third embodiment described below it has turned out to be difficult to achieve a firm joining in this area of the bag during manufacture without negatively influencing any neighbouring welding lines.
- At least the bottom wall sheet 4 has a layered structure consisting of at least two different outer layers. Both side wall sheets and the outer layer of the bottom wall sheet facing the side wall sheets during the welding process are preferably made from the same material. Using suitable materials for the sheets and layers it is possible to accomplish a tight and stable welding seal even though in fact four sheets are joined.
- the side wall sheets may have the same layered structure as the bottom wall sheet so that in this case all sheets can be made from the same material web.
- the other outer layer of the bottom wall sheet 4 which is at the surface of the folded bottom wall sheet where the folded parts of the bottom wall sheet face each other should preferably have a different, higher melting temperature than the first outer layer of the bottom wall sheet. As will become apparent in the example described below this has the advantage that the various welding steps can be conveniently separated.
- All three sheets 2 , 3 and 4 have a first outer layer made of polyethylene (PE) and a second outer layer made of polypropylene (PP) or polyamide (P A).
- the side wall sheets 2 and 3 are arranged before welding so that their PE layers face each other.
- the bottom wall layer 4 is folded so that the PP or P A layers of the folded parts face each other.
- the PE layers of the folded bottom wall sheet face the PE layers of each side wall sheet.
- both PE-PE welding zones thicknessick arrows in the right image of FIG.
- suitable welding methods can be chosen for the inner welding. Examples are ultrasonic or thermal contact welding methods.
- a layered structure in particular for the bottom wall sheet according to the third embodiment of the bag according to the invention to save the removal of sheet material is not limited to a variation of the second embodiment. It can also be utilised for the first embodiment or other variations of the bag according to the invention where four material sheets have to be joined.
- the embodiments of self-standing bags as explicitly disclosed in this patent document provide for an superior rigidity even if masses of 3 kg and more have to be provided and transported. Such bags may also be used for other purposes than for the transport of liquid dialysate concentrate. Loads of preferably four to six bags can easily be grouped together in hard paper boxes that can be piled on palettes thus allowing for convenient shipping of the filled bags. If the bags are manufactured at a different place than where the bags are filled they can be left in a flat configuration that permits efficient and non-bulky piling. Such bags, independent of whether being filled or being empty, are therefore explicitly considered as being a part of the concept of the disclosed invention.
Abstract
Description
- This is a continuation application of application Ser. No. 12/227,897 filed on Dec. 2, 2008, which is a national stage of PCT/EP07/0004879 filed Jun. 1, 2007 and published in English, which has a priority of European no. 06011472.5 filed Jun. 2, 2006, hereby incorporated by reference, and hereby claims the priority thereof.
- 1. Field of the Invention
- The invention relates to the field of containers for providing liquid concentrates for making ready-to-use dialysis fluid for a dialysis treatment of a patient by an artificial kidney.
- 2. Description of the Related Art
- In case of kidney failure the functions of the human kidneys have to be substituted by an artificial kidney device. Wide spread therapies comprise peritoneal dialysis and hemodialysis. In peritoneal dialysis, dialysis fluid is conducted via special implanted catheters to the peritoneal cavity of a patient and regularly exchanged with fresh fluid, thus purifying the human blood by diffusion of substances to be removed and by extracting excess water by osmotic pressure gradients through the peritoneum of the patient.
- In hemodialysis the blood of a patient is circulated in an extracorporeal blood circuit for several hours. The blood passes the blood chamber of a dialyser where a semipermeable membrane, most commonly in the shape of thousands of hollow fibres, separates a blood chamber from a dialysate chamber that is part of a dialysate circuit. The blood is purified from substances to be removed by diffusion through the membrane as such substances are 20 usually not contained in the dialysate flowing into the dialysate chamber. Other substances that are to be retained in the blood at least in certain concentrations and that can also pass the membranes like electrolytes are contained in the fresh dialysate in physiological concentrations. By applying a pressure gradient excess water can be transferred from the blood to the dialysate chamber and then be removed together with the dialysate exciting the dialysate chamber.
- Most contemporary hemodialysis devices prepare the dialysate required for the hemodialysis treatment during the treatment from concentrates and water in a single-pass system, i.e. the prepared dialysate only passes the dialyser once and is discarded thereafter. Depending on the type of dialysate to be used one or two concentrates are required. In the case of bicarbonate dialysis that currently represents the most common dialysis mode two concentrates are necessary because of chemical incompatibilities of some of the substances. The first or “A”-component usually consists of an acidic part that also contains most of the required electrolytes. The second or “B”-component consists mainly of sodium bicarbonate in this case. Whereas the second component can also be delivered in dry powder form, the first component is still widely distributed as a fluid in rigid containers if no central concentrate supply system exists where the concentrate is prepared at a central location and then distributed to the treatment places via a piping network.
- Typical dilution ratios of the A-component with water are about 1+33, 1+34 or 1+44, the B-component contributing further shares between 1 to 2 parts of liquid. Common dialysate flow rates for a hemodialysis treatment are of the order of 500 mllmin. Taking a four hour treatment a liquid volume of about 120 litres has to be circulated through the dialysate chamber requiring concentrate volumes of at least 3 to 4 litres each. To enable a variation of concentration ratios and also to provide a certain tolerance to prolong a treatment and to compensate the waste of dialysate in certain conditions of a hemodialysis device when for security reasons the continuously prepared dialysate is short-circuited to the drain, usual containers for liquid dialysate concentrates contain 5 or more litres of liquid concentrate.
- The dialysate prepared by diluting the concentrates with water on-line during a treatment of a patient may also be used as substitution liquid in the case of a hemofiltration or hemodiafiltration treatment. Today many treatment devices also provide for such on-line substitution modes leading to an even higher demand of liquid concentrates.
- Up to now the fluid concentrates have usually been delivered in rigid plastic containers as the weight of the concentrate requires a certain stability of the container. Such containers also simplify the shipping of large lots as they can easily be arranged in layers on top of each other.
- These rigid containers have the disadvantage that because of their rigidity they are comparatively expensive as the container walls have to be thick enough leading to higher material expenses. Furthermore, the empty containers are bulky making the further processing cumbersome. The large amount of material to be recycled or discarded adds further to the cost.
- It is an object of the present invention to provide a container with liquid dialysate that requires less material in the manufacturing process but still provides sufficient stability to the filled container even when being filled with three litres of liquid and more and during the use of the container when the container is gradually emptied.
- The problem of the invention is solved by a container filled with a liquid dialysate for making dialysate for a dialysis treatment, characterised in that the container is a self-standing bag made of flexible elastomeric sheets.
- The invention is based on the observation that in other technical fields self-standing bags made of flexible elastomeric sheets are in wide-spread use. Such bags require much less material for their production and much less space when being empty. However, there appeared to be the prejudice in the field of dialysis that such bags are not suitable for the manufacture of containers for liquid concentrates for dialysis. In fact the weight of several kilograrnms of liquid is large for a flexible bag bearing the risk that a bag may crack during use or not rest in a stable position to allow the extraction of the concentrate through the suction pipe of the hemodialysis device during a treatment procedure.
- In the framework of this patent application a self-standing bag is understood to be a bag having its barycentre well defined above its bottom standing area when being filled with a medium so that the filled bag rests in a stable standing orientation on its own.
- The inventors of the present invention observed that this prejudice can in fact be overcome and that it is possible to produce self-standing bags made of flexible elastomeric sheets filled with liquid dialysate concentrate having a volume of three litres and even more.
- In a preferred embodiment this bag is made from two elastomeric flexible side wall sheets having rectangular shape with horizontal top and bottom and two vertical edges, and one elastomeric flexible bottom wall sheet also having rectangular shape with two horizontal and two vertical edges. When being empty this bag may be put into a flat configuration where the bottom wall sheet is sandwiched between the two elastomeric side wall sheets and wherein the bottom wall sheet is symmetrically single-folded parallel to its horizontal edges and the horizontal edges of the bottom wall sheet coincide with the horizontal bottom edges of the two side wall sheets. In the flat configuration the empty bag is thus divided into a lateral four-layer part in the lower part of the bag and a lateral two-layer part in the upper part of the bag.
- A connector part can conveniently be sandwiched between the two horizontal top edges of the side wall sheets wherein the two horizontal top edges and the connector part are joined in a fluid tight way by a seal, preferably a welding line.
- In further embodiments of the invention several parts of the bag are jointly sealed, preferably by welding: the vertical edges of the side wall sheets in the lateral two-layer part, the vertical edges of the bottom wall sheet with the neighbouring parts of the side wall sheets, and the horizontal edges of the bottom wall sheet with the neighbouring horizontal bottom edges of the side wall sheets.
- A preferred embodiment of the bag comprises first sloped sealing lines on each side of the bag joining the side wall sheets in the lateral two-layer part between first points on the horizontal top edges of the side wall sheets that are recessed from the outer ends of the horizontal edges, in other words, the first points on the horizontal top edges of the side wall sheets are spaced from the vertical edges of the side wall sheets, and second points that are along or spaced from the vertical edges of the side wall sheets and that are positioned on the line separating the lateral two-layer part from the lateral four-layer part. Second sloped sealing lines join each side wall sheet and the neighbouring bottom wall sheet in the lateral four-layer part on each side of the bag between third points on the horizontal bottom edges that are recessed from the outer ends of the horizontal edges, in other words, the third points are spaced from the vertical edges of the side wall sheets, and the second points.
- The second points may be recessed from the vertical edges of the side wall sheets and the bag may comprise further horizontal sealing lines between the second points and the neighbouring vertical edges of the side wall sheets along the line separating the two-layer part from the four-layer part thus joining all four layers along these horizontal sealing lines.
- In a particularly stable embodiment of the self-standing bag there are third sloped sealing lines on each side of the bag between the third points and fourth points on the vertical edges of both the side wall sheets and the bottom wall sheet in the four-layer part joining only the bottom wall sheet and the neighbouring side wall sheet. Additional fourth sloped sealing lines on each side of the bag between the second and the fourth points joining only the bottom wall sheet and the neighbouring side wall sheet further contribute to the stability of the self-standing bag.
- In another embodiment of the invention the first, second and fourth sloped sealing lines, but not the third sloped sealing lines exist. Instead the sheet material of the side wall sheets and the bottom wall sheet in the corner areas below the second sloped sealing lines and below cutting edges leading from the fourth points to fifth points on the second sloped sealing lines is removed. The cutting edges may be reinforced by fifth sloped sealing lines on each side of the bag between the fourth and the fifth points joining only the bottom wall sheet (4) and the neighbouring side wall sheet. In this case a beak-like flap is formed on both sides of the bag that protects the zone around the second points where four sheets of the side wall sheets and the bottom wall sheet are joined.
- All sealing lines are preferably created by welding techniques, but generally other joining processes like gluing are also possible. In special cases a sealing line may simply be established by folding a larger sheet along the required line. Such embodiments are hereby explicitly encompassed by using the expression “seal” throughout this document. Furthermore, the sealing lines are preferably straight lines.
- In a particularly preferred embodiment of the self-standing bag the sheet material of the bottom wall sheet between the fourth sloped sealing lines and the vertical edges has been removing, preferably by punching. Both side wall sheets can therefore directly be joined in this area thus avoiding welding areas consisting of four layers of elastomeric sheets that could give rise to problems in reliable sealing the outer layers.
- The second sloped sealing line may at least partly be a peel seam that is adapted to absorb excessive pressure in the bag. Should high pressure suddenly develop in the bag as in the case of a crash of the bag on a hard floor the peel seam can at least partly open whereby the pressure is diminished in a controlled manner minimising the risk that the bag gets cracks.
- With the self-standing bag according to the invention it is possible to provide dialysate liquid concentrates in a bag made of elastomeric flexible sheets with common volumes of 3 to 8 litres, preferably 5 to 6 litres. Such a bag could also be delivered containing just a dry or slurry concentrate that when being diluted with water directly before use produces the same amount of dialysate liquid concentrate that is sufficient for a whole blood treatment of a patient.
- For embodiments of the self-standing bag according to the invention where the bag is made from two side wall and one bottom wall sheets a further advantageous embodiment makes use of a layered bottom wall sheet wherein the two outer layers consist of different materials. Using the same material for one outer layer of the bottom wall sheet and the side wall sheets or at least the outer layer of the side wall sheets facing each other further simplifies the manufacture of certain embodiments of the self-standing bag according to the invention as the stability of a bag area where four sheets would have to be joined by welding can be enhanced without the removal of parts of the bottom wall sheet.
- More details and advantages of the invention will become apparent from example embodiments of the container according to the invention as illustrated in a non-limiting manner in the drawings wherein
-
FIG. 1 a shows a first embodiment of the self-standing bag according to the invention in an empty, flat configuration, -
FIG. 1 b a lateral cross-section of the bag as indicated inFIG. 1 a, -
FIG. 2 the bag ofFIG. 1 a in a three-dimensional configuration when being filled, -
FIG. 3 the joining of the bottom and side wall sheets of the bag ofFIG. 2 , -
FIG. 4 the bag ofFIG. 2 with peel seams to absorb pressure waves, -
FIG. 5 an alternative embodiment of the bag ofFIG. 2 for avoiding any damage in the case of excessive pressure, -
FIG. 6 a table for preferred geometries of the example embodiments of the bag according to the invention, -
FIG. 7 a second embodiment of the self-standing bag according to the invention in an empty, flat configuration, -
FIG. 8 the bag ofFIG. 7 in a three-dimensional configuration when being filled, -
FIG. 9 the joining of the bottom and side wall sheets of the bag ofFIG. 8 , and -
FIG. 10 a third embodiment of the self-standing bag according to the invention showing a view similar toFIG. 9 for the second embodiment. - Further scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.
- In
FIG. 1 a a first embodiment of the self-standingbag 1 according to the invention is shown in a flat configuration directly after having been manufactured and before thebag 1 is filled with liquid dialysate concentrate.FIG. 1 b presents a lateral cross-section of thebag 1 as indicated inFIG. 1 a. The self-standingbag 1 is made from three rectangular sheets of flexible elastomeric material: two similarside wall sheets 2 and and onebottom wall sheet 4. Thebottom wall sheet 4 is sandwiched between theside wall sheets bottom wall sheet 4 is symmetrically single-folded parallel to itshorizontal edges horizontal bottom edges side wall sheets layer part 30 and a lateral two-layer part 20. Thevertical edges vertical edges - The two horizontal
top edges seal 10 wherein a connector part may be sandwiched and sealed between the side wall sheets in a part of the sealing line 10 (not shown inFIGS. 1 a and 1 b). Thevertical edges seals 11′ and 11″ in the lateral two-layer part 20 (an apostrophe in a reference sign shall denote parts on the left hand side of the bag and a double apostrophe the corresponding symmetric part on the right hand side in this patent document). - The
vertical edges side wall sheets further seals 12 a′, 12 b′ and 12 a″, 12 b″ (for parts that exist in the lateral four-layer part twice the suffix “a” is used in this patent document to denote an item that originates from the firstside wall sheet 2 and thebottom wall sheet 4 whereas the suffix “b” is used to denote the corresponding symmetric item that originates from the secondside wall sheet 3 and the bottom wall sheet 4). Furthermore thehorizontal edges horizontal bottom edges seals - As an alternative of making the bag from three separate sheets the
side wall sheets bottom wall sheet 4 may be made from a single web wherein thehorizontal bottom edges - The embodiment shown in
FIG. 1 a further comprises first slopedsealing lines 13′, 13″ between theside wall sheets layer part 20 on each side of the bag between first points A′, A″ on the horizontal topedges sealing line 10, that are recessed by a first distance a from the ends of the horizontal edges, and second points B′, B″ that are less or not recessed by a second distance b from thevertical edges layer part 20 from the lateral four-layer part 30. - The self-standing
bag 1 also comprises second sloped sealinglines 14 a′, 14 b′ and 14 a″ and 14 b″ joining eachside wall sheet bottom wall sheet 4 in the lateral four-layer part 30 on each side of the bag betweenthird points C 1′, C2′ and C1″, C2″ on thehorizontal bottom edges FIG. 1 a the first and third distances a and c are identical. Along the recesses with the second distance b and hence along the line separating the two-layer part 20 from the four-layer part 30 thebag 1 further compriseshorizontal sealing lines 15′, 15″ between the second points B′, B″ and the neighbouringvertical edges horizontal sealing lines 15′, 15″ join all four sheets in this region. - The
bag 1 also contains third sloped sealinglines 16 a′, 16 b′ and 16a″, 16b″ on each side of the bag between thethird points C 1′, C2′ andC 1″, C2″ andfourth points D 1′, D2′ andD 1″, D2″ on thevertical edges vertical edges layer part 30 joining only thebottom wall sheet 4 and the neighbouringside wall sheet fourth points D 1′, D2′ andD 1″, D2″ are recessed from the bottomhorizontal edges - In addition the self-standing
bag 1 comprises fourth sloped sealinglines 17 a′, 17 b′ and 17 a″, 17 b″ on each side of the bag between the second points B′, B″ and the fourth points D1′, D2′ and D1″, D2″ joining only thebottom wall sheet 4 and the neighbouringside wall sheet - All sealing lines are preferably produced by welding techniques for which a manifold of processes are available for those skilled in the art. By way of example the welding may be carried out by applying heat directly, using ultrasonic waves or laser irradiation.
- After the bag has been filled with liquid dialysate concentrate it assumes a three-dimensional shape as can be seen in
FIG. 2 . For reasons of clarity the liquid itself is not depicted inFIG. 2 . In this configuration the self-standing bag has a squaredbottom plane 40 whereas the interior has a wedge shaped volume with decreasing horizontal cross-section when going from the bottom to the top of thebag 1. This provides for a centre-of-gravity at low height and thus for an improved stability of the bag. The stability is also enhanced horizontally by the bottom side flaps 41 a′, 41 b′ and 41 a″, 41 b″ and vertically by the top side flaps 42′ and 42″. Also shown inFIG. 2 is aconnector part 50 that is sealed in a sandwiching manner between theside wall sheets line zone 10. -
FIG. 3 shows the joining process of the twoside wall sheets bottom wall sheet 4 in detail. To increase the stability of thebag 1 it is useful to join theareas 43′ and 44′ of the twoside wall sheets sloped sealing lines 17 a′, 17 b′ and thevertical edges bottom wall sheet 4, i.e. altogether four layers of elastomeric material would have to be welded together. Such welding procedures always bear the danger that a seal between any of the layers may be incomplete thus giving rise to increased instability and to forces that may damage other sealing lines and thus the integrity of the whole bag. - In the embodiment of the bag according to the invention that is shown in
FIG. 3 the correspondingparts 45 a′ and 45 b′ of thebottom wall sheet 4 are therefore punched out from thebottom wall sheet 4 and removed before all sheets are joined as displayed inFIG. 3 . Now a direct welding seal between theareas 43′ and 44′ of the twoside wall sheets bottom wall sheet 4. - In order to avoid or minimise any damage of critical sealing lines in the case of the development of pressure waves in the liquid concentrate in the container should the bag be dropped accidentally, some of the sealing lines may at least partly consist of peel seams. In
FIG. 4 the bag ofFIG. 2 is shown wherein the firstsloped sealing lines 13′, 13″ are made of such peelable seams. Should a pressure wave as a result of excessive pressure in the bag hit the various sealing lines of the bag the peel seams 13′, 13″ can partly or completely open, thereby absorbing and reducing the pressure and relieving the other sealing lines from a critical pressure condition. - An alternative solution to absorb excessive pressure is provided in
FIG. 5 . In this embodiment the firstsloped sealing lines 13′, 13″ are interrupted at the top of the bag. Should the bag be dropped (step 1) the pressure wave (step 2) expands into all directions and also to the air remaining at the top of the container (step 3), which further expands into the topside flap chambers 42′,42″ (step 4). As the total sealing line length is larger in this case as for the bag shown inFIG. 2 and as the air or liquid can also expand within theflexible flaps 42′, 42″ the pressure in the whole bag can significantly be reduced. As the firstsloped sealing lines 13′, 13″ are only interrupted at a small length compared to their total length the stability of thebag 1 is not diminished. - With the aid of the bag according to the invention it is possible to provide 3 to 8 litres, preferably 5 to 6 litres of liquid dialysate concentrate in a self-standing bag made of elastomeric and flexible material sheets. The design of the bag guarantees that the bag remains in a stable upright position during use even when the bag contains less and lesser liquid at the end of a hemodialysis treatment.
- Preferred geometries of the embodiment of a self-standing bag according to the invention as shown in the
FIGS. 1 to 5 are provided inFIG. 6 . - The self-standing
bag 1 most conveniently contains arigid connector part 50 as shown inFIGS. 2 , 4 and 5. Theconnector part 50 has a wide middle part section and two tapered side wing parts to enable smooth transitions for thetop sealing line 10. Anorifice 53 in the wide middle part has a diameter large enough for a suction pipe of a dialysis device to reach into the interior of the bag. Any air tight sealing between the bag and the suction pipe is not necessary as in the case of conventional containers made of rigid material. Theorifice 53 may comprise an inner, smaller orifice (not shown) as spill barrier. - The orifice can be closed after the bag has been filled by a tamper-proved
lid 51 that may also be used to re-close the bag after use. Theconnector part 50 preferably comprises ahandle 52 by which the whole bag can easily be carried. Thehandle 52 is linked to the main part of theconnector 50 by suitable joints so that thehandle 52 can be moved out of the way of theorifice 53 of theconnector part 50 when a suction pipe is to be inserted into the bag. - Instead of a tamper-proved lid 51 a peelable disposable sheet may also be used to close the bag after filling, e.g. by appropriate heat sealing to the
orifice 53. Such an embodiment is less costly and also provides a single-use indication as the sheet cannot be applied to the orifice again once it has been removed. - In
FIG. 7 a second embodiment of the self-standingbag 1 according to the invention is shown in a view similar to that ofFIG. 1 a. The same reference numbers are used for identical parts of both embodiments of the bag. The cross-section as displayed inFIG. 1 b is the same for the second embodiment which is why this view is omitted here. - As in the first embodiment the
bag 1 shown inFIG. 7 also comprises the firstsloped sealing lines 13′, 13″ between the first points A′, A″ and the second points B′, B″, the secondsloped lines 14 a′, 14 a″ and 14 b′, 14 b″ between the second points B′, B″ and the third points C1′, C1″ and C2′, C2″ and the fourthsloped sealing lines 17 a′, 17 a″ and 17 b′, 17 b″ between the second points B′, B″ and the fourth points D1′, D1″ and D2′, D2″. However, the third sealing lines of the first embodiment are not present in the second embodiment. Instead the sheet material of theside wall sheets bottom wall sheet 4 in thecorner areas 47 a′, 47 b′ and 47 a″, 47 b″ below the fourthsloped sealing lines 17 a′, 17 a″ and 17 b′, 17 b″ and below cuttingedges 48 a′, 48 a″ and 48 b′, 48 b″ leading from the fourth points D1′, D1″ and D2′, D2″ to fifth points E1′, E1″ and E2′, E2″ on the secondsloped sealing lines 14 a′, 14 a″ and 14 b′, 14 b″ is removed, wherein the fifth points E1′, E1″ and E2′, E2″ are recessed from thehorizontal bottom edges - The
bag 1 may comprise fifthsloped sealing lines 19 a′, 19 a″ and 19 b′, 19 b″, preferably welding lines, on each side of the bag between the fourth and the fifth points joining only thebottom wall sheet 4 and the neighbouringside wall sheet 2; 3 directly at the cutting edges 48 a′, 48 a″ and 48 b′, 48 b″. -
FIG. 8 shows the self-standingbag 1 according to the second embodiment of the invention in a three-dimensional configuration when being filled similar to the view ofFIG. 2 . For reasons of clarity the liquid itself is again not depicted. In this configuration the inner part of the self-standingbag 1 is similar for both embodiments which leads to a comparable position of the centre-of-gravity. The vertical stability is also enhanced by the top side flaps 42′ and 42″ and the sealing lines at their edges. However, the horizontal stability is achieved by the secondsloped sealing lines 14 a′, 14 b′ and 14 a″, 14 b″ and the creation of beak-like flaps 46 a′, 46 b′ and 46 a″, 46 b″ on both sides of the filledbag 1. These beak-like flaps protect the zones around the second points B′, B″, where four sheets of the side wall sheets and the bottom wall sheet are joined, from any stress that results from the fluid inside thebag 1 statically and dynamically when the bag is moved or dropped. At the same time the flaps enhance the horizontal stability of the second sloped sealing lines as they provide a constraint between the secondsloped sealing lines 14 a′, 14 a″ between the oneside wall sheet 2 and thebottom wall sheet 4 and the corresponding second sloped sealinglines 14 b′, 14 b″ between the otherside wall sheet 3 and thebottom wall sheet 4. - As depicted in
FIG. 9 the joining of the bottom and side wall sheets of the bag can be realised for the second embodiment of the self-standingbag 1 similarly as in the case of the first embodiment. The description ofFIG. 3 therefore applies mutatis mutandis toFIG. 9 . Also the concepts as disclosed inFIGS. 4 and 5 can easily be combined with the design of the self-standing bag according to the second embodiment. - Preferred geometries of the second embodiment of the self-standing bag according to the invention are also compiled in the table of
FIG. 6 . -
FIG. 10 shows an alternative for the joining of the bottom and side wall sheets according to a third embodiment of the self-standing bag according to the invention. The third embodiment is similar to the second embodiment but theparts 45 a′ and 45 b′ of thebottom wall sheet 4 are not punched out and removed before all sheets are joined. Instead a welding between theareas 43′ and 44′ of the twoside wall sheets bottom wall sheet 4 can be established. Without the modification according to the third embodiment described below it has turned out to be difficult to achieve a firm joining in this area of the bag during manufacture without negatively influencing any neighbouring welding lines. - In this embodiment at least the
bottom wall sheet 4 has a layered structure consisting of at least two different outer layers. Both side wall sheets and the outer layer of the bottom wall sheet facing the side wall sheets during the welding process are preferably made from the same material. Using suitable materials for the sheets and layers it is possible to accomplish a tight and stable welding seal even though in fact four sheets are joined. The side wall sheets may have the same layered structure as the bottom wall sheet so that in this case all sheets can be made from the same material web. The other outer layer of thebottom wall sheet 4 which is at the surface of the folded bottom wall sheet where the folded parts of the bottom wall sheet face each other should preferably have a different, higher melting temperature than the first outer layer of the bottom wall sheet. As will become apparent in the example described below this has the advantage that the various welding steps can be conveniently separated. - The following combination of material layers has proven to be particularly advantageous. All three
sheets side wall sheets bottom wall layer 4 is folded so that the PP or P A layers of the folded parts face each other. After having been inserted between the side wall sheets the PE layers of the folded bottom wall sheet face the PE layers of each side wall sheet. As the PP-PP or PA-PA welding requires higher melting temperatures compared with the PE-PE welding, both PE-PE welding zones (thick arrows in the right image ofFIG. 10 ) can be created by using conventional welding tools to create the necessary temperature without simultaneously welding the PP-PP or PA-PA contact area, leaving the folded bottom wall sheet not sticking or welded to itself. The use of conventional welding tools enables in this case the formation of additional welding lines of the bag at the same time. In a subsequent process step it is then possible to locally heat up only theareas 43′ and 44′ again to then deliberately join the inner PP-PP or PA-PA surfaces (thick arrows in the left enlargement image ofFIG. 10 ). The local melting of the PE-PE welds in these areas has no consequences as the welds are simply formed again, and the remainder of the PE-PE welds are not influenced at all. - Depending on the material suitable welding methods can be chosen for the inner welding. Examples are ultrasonic or thermal contact welding methods.
- Using a layered structure in particular for the bottom wall sheet according to the third embodiment of the bag according to the invention to save the removal of sheet material is not limited to a variation of the second embodiment. It can also be utilised for the first embodiment or other variations of the bag according to the invention where four material sheets have to be joined.
- The embodiments of self-standing bags as explicitly disclosed in this patent document provide for an superior rigidity even if masses of 3 kg and more have to be provided and transported. Such bags may also be used for other purposes than for the transport of liquid dialysate concentrate. Loads of preferably four to six bags can easily be grouped together in hard paper boxes that can be piled on palettes thus allowing for convenient shipping of the filled bags. If the bags are manufactured at a different place than where the bags are filled they can be left in a flat configuration that permits efficient and non-bulky piling. Such bags, independent of whether being filled or being empty, are therefore explicitly considered as being a part of the concept of the disclosed invention.
- The invention being thus described, it will be apparent that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications as would be recognized by one skilled in the art are intended to be included within the scope of the following claims.
Claims (24)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/570,124 US8882737B2 (en) | 2006-06-02 | 2012-08-08 | Container filled with a liquid concentrate for making dialysate |
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP06011472 | 2006-06-02 | ||
EP06011472A EP1862189B1 (en) | 2006-06-02 | 2006-06-02 | Container filled with a liquid concentrate for making dialysate |
EP06011472.5 | 2006-06-02 | ||
PCT/EP2007/004879 WO2007140942A1 (en) | 2006-06-02 | 2007-06-01 | Container filled with a liquid concentrate for making dialysate |
US22789708A | 2008-12-02 | 2008-12-02 | |
US13/570,124 US8882737B2 (en) | 2006-06-02 | 2012-08-08 | Container filled with a liquid concentrate for making dialysate |
Related Parent Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2007/004879 Continuation WO2007140942A1 (en) | 2006-06-02 | 2007-06-01 | Container filled with a liquid concentrate for making dialysate |
US12/227,897 Continuation US8251971B2 (en) | 2006-06-02 | 2007-06-01 | Container filled with a liquid concentrate for making dialysate |
US22789708A Continuation | 2006-06-02 | 2008-12-02 |
Publications (2)
Publication Number | Publication Date |
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US20130071048A1 true US20130071048A1 (en) | 2013-03-21 |
US8882737B2 US8882737B2 (en) | 2014-11-11 |
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US12/227,897 Active 2029-01-14 US8251971B2 (en) | 2006-06-02 | 2007-06-01 | Container filled with a liquid concentrate for making dialysate |
US13/570,124 Active US8882737B2 (en) | 2006-06-02 | 2012-08-08 | Container filled with a liquid concentrate for making dialysate |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
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US12/227,897 Active 2029-01-14 US8251971B2 (en) | 2006-06-02 | 2007-06-01 | Container filled with a liquid concentrate for making dialysate |
Country Status (18)
Country | Link |
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US (2) | US8251971B2 (en) |
EP (2) | EP1862189B1 (en) |
JP (1) | JP5175276B2 (en) |
KR (1) | KR101412442B1 (en) |
CN (2) | CN101443056B (en) |
AT (1) | ATE519512T1 (en) |
AU (1) | AU2007256457B2 (en) |
BR (1) | BRPI0712573B8 (en) |
CA (1) | CA2646042C (en) |
CY (1) | CY1117516T1 (en) |
DK (2) | DK1862189T3 (en) |
EA (1) | EA017416B1 (en) |
ES (2) | ES2396907T3 (en) |
HK (2) | HK1133838A1 (en) |
HU (1) | HUE027297T2 (en) |
PL (2) | PL1862189T3 (en) |
SI (1) | SI2029193T1 (en) |
WO (1) | WO2007140942A1 (en) |
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US11878841B2 (en) | 2015-09-09 | 2024-01-23 | Kao Corporation | Sheet material container |
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US11878841B2 (en) | 2015-09-09 | 2024-01-23 | Kao Corporation | Sheet material container |
US11129928B2 (en) | 2016-07-06 | 2021-09-28 | Serres Oy | Assembly for collecting fluid during a medical or a surgical operation |
US11285255B2 (en) | 2016-07-06 | 2022-03-29 | Serres Oy | Collection liner for a medical or a surgical operation |
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